Blaine Labs Inc.
Form 483 issued December 15, 2023 · Santa Fe Springs, California
- Inspection
- Dec 1 – Dec 15, 2023
- Investigator
- Darren S. Brown
- Observations
- 4
- Pages
- 4
- FEI number
- 3001744192
In short: On December 15, 2023, FDA issued a Form 483 with 4 observations to Blaine Labs Inc. in Santa Fe Springs, California (FEI 3001744192) after an inspection that ran Dec 1 – Dec 15, 2023. The investigator was Darren S. Brown. Most observations concern quality system and production.
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
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) 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 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Blaine Labs Inc.?
Darren S. Brown is named on this Form 483, for the inspection of Dec 1 – Dec 15, 2023. Each investigator has a profile showing what they cite most.
When was Blaine Labs Inc. inspected by FDA?
The inspection ran Dec 1 – Dec 15, 2023, and the Form 483 is dated December 15, 2023.
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.