Blaine Labs Inc.
Form 483 issued August 24, 2021 · Santa Fe Springs, California
- Inspection
- Aug 17 – Aug 24, 2021
- Investigators
- Cecilia H. Kieu· Liming Zhang
- Observations
- 12
- Pages
- 10
- FEI number
- 3001744192
In short: On August 24, 2021, FDA issued a Form 483 with 12 observations to Blaine Labs Inc. in Santa Fe Springs, California (FEI 3001744192) after an inspection that ran Aug 17 – Aug 24, 2021. The investigators were Cecilia H. Kieu and Liming Zhang. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmBlaine Labs Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blaine Labs Inc.?
FDA listed 12 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Blaine Labs Inc.?
Cecilia H. Kieu and Liming Zhang are named on this Form 483, for the inspection of Aug 17 – Aug 24, 2021. Each investigator has a profile showing what they cite most.
When was Blaine Labs Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 24, 2021, and the Form 483 is dated August 24, 2021.
How do I get the full Form 483 for Blaine Labs Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.