FDA Inspection
Intact Pharmaceuticals LLCIntact Pharmaceuticals LLC – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns Intact Pharmaceuticals LLC, with an inspection on October 12, 2018, issued by the New England District Office, covering human drugs.
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ID · 31cc50ed-0fd8-4b7c-a048-ee49484b623b
Inspection Facts
- Inspection number
- 1069485
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
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