FDA Steps Up Records Scrutiny In GMP Inspections

FDA inspectors are no longer content with only seeing that records are kept by supplement manufacturers. The agency is warning companies that GMP compliance requires maintaining comprehensive batch production records, including information on applicable manufacturing procedures.

As promised, FDA inspectors are drilling down into dietary supplement manufacturers’ recordkeeping processes, no longer content simply to see that records are kept but reviewing the records’ thoroughness. Warning letters citing deviations from the supplement good manufacturing practices final rule show FDA is paying close attention to incomplete batch production records that lack information on applicable manufacturing procedures and the specific equipment used in production. The agency’s most recently posted supplement GMP warning letters are compiled below.

Recipient	Warning Letter Date	Inspection Dates	Warning Letter Highlights
Algaen Corp. (Winston-Salem, N.C.)	March 8, 2013	July 31 – Aug. 1, 2012	Algaen, maker of AlgaBerry products, has “not prepared and kept written procedures for personnel, including written procedures for preventing microbial contamination, hygienic practices, and personnel qualification requirements.” Among the hygienic practices not recorded were “wearing outer garments in a manner that protects against contamination hand washing, removal of unsecured jewelry prior to working with ingredients, maintaining gloves used in handling of components, wearing, where appropriate, hair restraints, not storing clothing or other personal belongings in certain areas, and other steps that would protect against contamination.”
ProNatural Nutrition LLC (Cedar City, Utah)	July 19, 2013	Oct. 11-22, 2012	FDA cited ProNatural Nutrition for selling unapproved new drugs with colloidal silver. The firm’s batch production records also lacked the identity of equipment used, statements of processing yields and the results of testing performed during production. ProNatural’s Nov. 14 response to FDA said, “‘We will update the written checklist of what is required and what will be a part of every production batch records.’ Besides paraphrasing the deviations noted on the 483, to date, you have not provided any additional documentation so that we can ascertain the implementation of your proposed corrective actions; therefore, we deem your response unacceptable.”
N.V.E. Pharmaceuticals Inc. (Andover, N.J.)	July 22, 2013	Sept. 11-26, 2012	N.V.E.’s procedure for handling product complaints “lacks details and directions for obtaining and documenting product information, complaint information, and the review, disposition, and follow-up actions taken for product complaints. … From October 2011 through June 2012, you received 29 health related complaints, including a complaint of a heart attack, a possible allergic reaction, jittery, sick feeling, and a rash. You were unable to provide all this information to our investigators as required for product complaints. These products include Stacker 2 brand: XPLC; Stacker 2; Black Jax; Yellow Hornet. … While corrective measures were documented in your Jan. 15, 2013, response, you did not provide supporting information to demonstrate that the products documented during the inspection were part of any corrective actions.”
Natural Products Services Inc. (Escondido, Calif.)	July 23, 2013	Oct. 11-22, 2012	Natural Products Services, which makes CircuForce and HealthForce Liver Rescue 4+, “did not make and keep records of the written procedures for manufacturing operations. You must also establish and follow written procedures for manufacturing operations.” FDA said the firm’s Nov. 7 response was “inadequate. You state ‘The use of the major pieces of equipment [in] the operations area is identified within the Batch Production Records for Dietary Supplement Products’ and refer to the BPR for Truly Natural Vitamin C that you provided in your response as an example. The BPR identifies the equipment used in manufacturing the batch; however, it does not include the applicable manufacturing procedures.”