FDA Inspection
SOCIETAL CDMO SAN DIEGO, LLCSOCIETAL CDMO SAN DIEGO, LLC – FDA Inspection, Mar 13, 2018
Record Details
This FDA Inspection record concerns SOCIETAL CDMO SAN DIEGO, LLC, with an inspection on March 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christopher M. Reed (Issuing Officer)
- Linda Thai (FDA Associated Person)
- Walden H. Lee (FDA Associated Person)
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ID · 4f676b9c-f387-4ba0-8a35-e93e53ca47fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044479
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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| August 28, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
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