FDA Inspection
PAI Holdings, LLC, dba Pharmaceutical Associates, IncPAI Holdings, LLC, dba Pharmaceutical Associates, Inc – FDA Inspection, Jun 15, 2012
Record Details
This FDA Inspection record concerns PAI Holdings, LLC, dba Pharmaceutical Associates, Inc, with an inspection on June 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 15, 2012
- Product Type
- Drugs
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ID · 08d9993c-9b35-4892-8a60-146ad71cf2f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788106
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| December 13, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 995279 - 2016-12-13
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