FDA Inspection
PAI Holdings, LLC, dba Pharmaceutical Associates, IncPAI Holdings, LLC, dba Pharmaceutical Associates, Inc – FDA Inspection, Dec 13, 2016
Record Details
This FDA Inspection record concerns PAI Holdings, LLC, dba Pharmaceutical Associates, Inc, with an inspection on December 13, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 13, 2016
- Product Type
- Drugs
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Jessica P. Mcalister (FDA Associated Person)
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ID · 8bb5a7ec-267a-4e44-a57c-8267f2ee79d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995279
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 2, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 28, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
- FDA Inspection 1229199 - 2024-04-17
- FDA Inspection 1180090 - 2022-09-02
- FDA Inspection 1043040 - 2018-01-16
- FDA Inspection 1036787 - 2017-11-09
- FDA Inspection 928826 - 2015-05-28
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