FDA Inspection
Professional Partners, Inc./ Westcliff Compounding PharmacyProfessional Partners, Inc./ Westcliff Compounding Pharmacy – FDA Inspection, May 9, 2016
Record Details
This FDA Inspection record concerns Professional Partners, Inc./ Westcliff Compounding Pharmacy, with an inspection on May 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 9, 2016
- Product Type
- Drugs
View Company Profile
ID · 4ebde46e-1845-42b5-b479-4afe7252b493
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974716
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- State Referral Letter
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.