DLC Laboratories, Inc.
Form 483 issued December 12, 2019 · Paramount, California
- Inspection
- Dec 9 – Dec 12, 2019
- Investigators
- Jeffrey P. Raimondi· Kouros Kangarli
- Observations
- 8
- Pages
- 8
- FEI number
- 2020223
In short: On December 12, 2019, FDA issued a Form 483 with 8 observations to DLC Laboratories, Inc. in Paramount, California (FEI 2020223) after an inspection that ran Dec 9 – Dec 12, 2019. The investigators were Jeffrey P. Raimondi and Kouros Kangarli. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include documentation of…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmDLC Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DLC Laboratories, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected DLC Laboratories, Inc.?
Jeffrey P. Raimondi and Kouros Kangarli are named on this Form 483, for the inspection of Dec 9 – Dec 12, 2019. Each investigator has a profile showing what they cite most.
When was DLC Laboratories, Inc. inspected by FDA?
The inspection ran Dec 9 – Dec 12, 2019, and the Form 483 is dated December 12, 2019.
How do I get the full Form 483 for DLC Laboratories, 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.