FDA Inspection
Oakmont Products, LLCOakmont Products, LLC – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Oakmont Products, LLC, with an inspection on July 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Louis S. Chen (Issuing Officer)
- Rita K. Vick (Issuing Officer)
- Shaun M Stracener (Issuing Officer)
View Company Profile
ID · c41a6e66-3425-4533-8c4a-1fa8b876ddf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058777
- FDA center
- Human Drugs
- Project area
- Over-the-Counter Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(a)Written in-process control procedures
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.