PT Eka Wira Asia - Corporate Office · 80-04 · INDONESIA
For PT Eka Wira Asia - Corporate Office, import alert is 80-04; country is INDONESIA; import alert name is "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"; product code is 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 09/16/2009; address is J1. Prof Hm Yamin No. 40-40a , Medan, INDONESIA, verified against its source on 2026-09-30.
- Firm
- PT Eka Wira Asia - Corporate Office verified
- Import alert
- 80-04
- Import alert name
- "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"
- Country
- INDONESIA verified
- Address
- J1. Prof Hm Yamin No. 40-40a , Medan, INDONESIA verified
- Date published
- 09/16/2009 verified
- Product code
- 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty each item verified
- Product
- A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. each item verified
- FDA notes
- *** Level 3 (3/10/1999) Note | *** Level 3 (3/10/1999)Note | *** Level 3 (3/10/1999) Note | *** Level 3 (3/10/1999) Note | *** Level 3 (3/10/1999)Note each item verified
What the source says
PT Eka Wira Asia - Corporate Office Date Published : 09/16/2009 J1. Prof Hm Yamin No. 40-40a , Medan, INDONESIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
80 F - - MC Glove, Patient Examination Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (3/10/1999) Note 80 L - - YY Glove, Patient Examination, Latex Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (3/10/1999)Note 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (3/10/1999) Note 80 L - - ZA Glove, Patient Examination, Poly Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (3/10/1999) Note 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (3/10/1999)Note
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_229.html
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