Enviornmental Data Integrity

As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits.  The firm reported that they had no results outside limits for over a year prior to the inspection date…

However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017.… more


Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.

Section III identifies Inspections and Enforcement of Compounders.  This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities. … more

2018 503B Smoke Study Issues

In the first 6-months of 2018, fiftteen 503B Outsourcing Facilities were cited for smoke study issues.  Airflow is critical in maintaining sterile conditions, as described in the FDA Guide on Aseptic Processing

In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. … more

Critical Airflow Visualization Data Integrity

Aseptic manufacturing facilities have many critical qualification activities that rely heavily on high-quality data collection. One such activity is critical airflow visualization – commonly referred to as a smoke study. Smoke studies are used to demonstrate “laminarity and sweeping action over and away from the product under dynamic conditions” (FDA draft guidance “Sterile Drug Products Produced by Aseptic Processing”).more


On May 29, 2018 FDA posted 9 warning letters to online retailers whose networks offered or introduced into interstate commerce, opioids that are misbranded and unapproved new drugs, in violation of sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C.… more

What is a Facility – Updated

September 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act.  In May 2018, the draft guiance was approved and published in the Federal Register and is available here.

Industry Questions:

FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to patient specific prescriptions under section 503A, and not follow CGMP requirements in that area.… more

OTC Manufacturer Warning Letter

Recently a manufacturer of an OTC product was inspected by FDA (Nov 2017) and the resultant warning letter was posted on the FDA website May 2018.  This firm received 3 citations which are summarized below:

Observation 1 – the firm elected to manufacture the OTC product with raw material that had not been tested and released by the quality unit. … more

Software as a Medical Device (SaMD): Clinical Evaluation and Validation

Your doctor is probably not using the data from your wearable (e.g. fitbit) to make decisions about your health. However, this is the kind of question we begin to ask when considering Software as a Medical Device (SaMD). By definition, these are applications (software) intended for medical use without the use of hardware (International Medical Device Regulators Forum (IMDRF) guidance).more

Come on Man

Come On Man…

if you watch ESPN Sports Center you have probably heard the announcers do their Come on Man bit.  Well perhaps we should have something similar for the pharmaceutical industry when they do something just plain dumb….

How about a CMO in North Carolina that recently received a FDA warning letter


Certificate of Analysis

Question: Can I use my vendor’s Certificate of Analysis when making a pharmaceutical product or compounding a product as a 503B outsourcing facility?  Yes – BUT in accordance with 21 CFR 211.84(d)(1) and (2):

(d) Samples shall be examined and tested as follows:

(1) At least one test shall be conducted to verify the identity of each component of a drug product.… more