PT. Eka Wira Asia · 80-04 · INDONESIA
For PT. Eka Wira Asia · 80-04 · INDONESIA, import alert is 80-04; import alert name is "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"; country is INDONESIA; 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 Jln. Zainal Arifin , 128 B-C , Medan, Sumatera Utara INDONESIA, verified against its source on 2026-09-16.
- Firm
- PT. Eka Wira Asia 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
- Jln. Zainal Arifin , 128 B-C , Medan, Sumatera Utara 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 Date Published : 09/16/2009 Jln. Zainal Arifin , 128 B-C , Medan, Sumatera Utara INDONESIA 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_229.html
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