Spectrum Laboratory Products, Inc.
Form 483 issued March 14, 2016 · New Brunswick, New Jersey
- Observations
- 8
- Pages
- 6
- FEI number
- 2246824
In short: On March 14, 2016, FDA issued a Form 483 with 8 observations to Spectrum Laboratory Products, Inc. in New Brunswick, New Jersey (FEI 2246824). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
5 of 8 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (3×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Active Pharmaceutical Ingredients are not…
- 02
Changes to approved and released analytical testing data for incoming Active Pharmaceutical Ingredients (APIs) is not…
- 03
Modifications to established USP/NF compendia methods are performed…
- 04
Improper storage and monitoring of…
This inspection in context
Questions about this 483
What did FDA find at Spectrum Laboratory Products, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Spectrum Laboratory Products, Inc. inspected by FDA?
This Form 483 is dated March 14, 2016.
How do I get the full Form 483 for Spectrum Laboratory Products, 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.