FDA Inspection
Blaine Labs IncBlaine Labs Inc – FDA Inspection, Sep 30, 2019
Record Details
This FDA Inspection record concerns Blaine Labs Inc, with an inspection on September 30, 2019, issued by the Los Angeles District Office, covering human drugs.
View Company Profile
ID · c5baaab3-4466-42c7-b669-58fbd2619550
Inspection Facts
- Inspection number
- 1103359
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blaine Labs Inc
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| December 15, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 24, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Blaine Labs Inc
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.