Blaine Labs Inc.
Form 483 issued September 30, 2019 · Santa Fe Springs, California
- Inspection
- Sep 25 – Sep 30, 2019
- Investigator
- Liming Zhang
- Observations
- 13
- Pages
- 10
- FEI number
- 3001744192
In short: On September 30, 2019, FDA issued a Form 483 with 13 observations to Blaine Labs Inc. in Santa Fe Springs, California (FEI 3001744192) after an inspection that ran Sep 25 – Sep 30, 2019. The investigator was Liming Zhang. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 9 of 13 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
This inspection in context
Liming Zhang
19 documents · 2014–2021
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blaine Labs Inc.?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Blaine Labs Inc.?
Liming Zhang is named on this Form 483, for the inspection of Sep 25 – Sep 30, 2019. Each investigator has a profile showing what they cite most.
When was Blaine Labs Inc. inspected by FDA?
The inspection ran Sep 25 – Sep 30, 2019, and the Form 483 is dated September 30, 2019.
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.